Open-label Extension Study of the Phase 3 VRX-RET-E22-301 Double-Blind Trial



Status:Completed
Conditions:Neurology, Epilepsy
Therapuetic Areas:Neurology, Other
Healthy:No
Age Range:18 - 75
Updated:4/17/2018
Start Date:May 1, 2006
End Date:March 15, 2017

Use our guide to learn which trials are right for you!

A Multicenter, Open-label, Long-term, Safety, Tolerability and Efficacy Study of Retigabine in Adult Epilepsy Patients With Partial-onset Seizures (Extension of Study VRX-RET-E22-301)

The purpose of this study is to evaluate the safety and tolerability of long-term therapy
with retigabine administered as adjunctive therapy in adult epilepsy patients with
partial-onset seizures, who completed the VRX-RET-E22-301 double-blind study. The efficacy of
long-term treatment with retigabine and patient quality of life will also be assessed.

This Phase 3 trial is an open-label extension study of the placebo-controlled, double-blind
VRX-RET-E22-301 trial. Patients who have completed the VRX-RET-E22-301 trial and who meet
inclusion and exclusion criteria will be treated with 600-1200 mg/day of retigabine as an
adjunct therapy to their current antiepileptic drugs (AEDs) or vagal nerve stimulation.
Treatment will be continued until retigabine is commercially available, or until the program
is discontinued. Patients will be recruited from 45-50 sites in the United States, Canada,
Mexico, Brazil, and Argentina. The safety and tolerability of long-term therapy with
retigabine administered as adjunctive therapy in adult epilepsy patients with partial-onset
seizures will be evaluated. In addition, the efficacy of long-term treatment with retigabine
and patient quality of life will be assessed.

Inclusion Criteria:

- Patient has successfully completed the Maintenance and Transition phases of Study
VRX-RET-E22-301 for the treatment of partial-onset seizures

- Patient is expected to benefit from participation in the study in the opinion of the
Investigator.

Exclusion Criteria:

- Patient meets any of the withdrawal criteria in the previous VRX-RET-E22-301 study or
is experiencing an ongoing serious adverse event.

- Patient is receiving any investigational drug or using any experimental device in
addition to Retigabine for treatment of epilepsy or any other medical condition.

- Patient has any other condition that would prevent compliance with the study
procedures or proper reporting of adverse events.
We found this trial at
31
sites
Bethesda, Maryland 20817
?
mi
from
Bethesda, MD
Click here to add this to my saved trials
7777 Forest Ln # C840
Dallas, Texas 75230
(972) 566-7000
Medical City Dallas Hospital If you have concerns for your health, that of a family...
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Jacksonville, Florida 32209
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
Miami, Florida 33124
(305) 284-2211
University of Miami A private research university with more than 15,000 students from around the...
?
mi
from
Miami, FL
Click here to add this to my saved trials
1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
?
mi
from
Nashville, TN
Click here to add this to my saved trials
305 1st Avenue # Dazian 7
New York, New York 10003
(212) 420-2806
Beth Israel Med Ctr The physicians and staff of Mount Sinai Beth Israel's Heart Institute...
?
mi
from
New York, NY
Click here to add this to my saved trials
Ames, Iowa 50010
McFarland Clinic, PC It has been over 65 years since the founders of McFarland Clinic...
?
mi
from
Ames, IA
Click here to add this to my saved trials
Asheville, North Carolina 28806
?
mi
from
Asheville, NC
Click here to add this to my saved trials
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
Capital Federal, CBA
?
mi
from
Capital Federal,
Click here to add this to my saved trials
?
mi
from
Charlottesville, VA
Click here to add this to my saved trials
?
mi
from
Chesterfield, MO
Click here to add this to my saved trials
Colorado Springs, Colorado 80918
?
mi
from
Colorado Springs, CO
Click here to add this to my saved trials
Dallas, Texas 75230
?
mi
from
Dallas, TX
Click here to add this to my saved trials
?
mi
from
Denver, CO
Click here to add this to my saved trials
2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
?
mi
from
Detroit, MI
Click here to add this to my saved trials
Hershey, Pennsylvania 17033
?
mi
from
Hershey, PA
Click here to add this to my saved trials
Houston, Texas 77030
?
mi
from
Houston, TX
Click here to add this to my saved trials
?
mi
from
Huntsville, AL
Click here to add this to my saved trials
La Jolla, California 92037
?
mi
from
La Jolla, CA
Click here to add this to my saved trials
Lexington, Kentucky
859) 257-9000
University of Kentucky The University of Kentucky is a public, land grant university dedicated to...
?
mi
from
Lexington, KY
Click here to add this to my saved trials
Little Rock, Arkansas 72205
?
mi
from
Little Rock, AR
Click here to add this to my saved trials
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Los Angeles, California 90073
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Northport, Alabama 35476
?
mi
from
Northport, AL
Click here to add this to my saved trials
Phoenix, Arizona 85013
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
1250 E. Marshall St.
Richmond, Virginia 23298
(804) 828-9000
Virginia Commonwealth University Medical Center The Virginia Commonwealth University Health System is an urban, comprehensive...
?
mi
from
Richmond, VA
Click here to add this to my saved trials
Saint Paul, Minnesota
?
mi
from
Saint Paul, MN
Click here to add this to my saved trials
Sarasota, Florida 34233
?
mi
from
Sarasota, FL
Click here to add this to my saved trials
?
mi
from
Toledo, OH
Click here to add this to my saved trials
Tualatin, Oregon 97062
?
mi
from
Tualatin, OR
Click here to add this to my saved trials